[Governance of innovative cardiovascular devices: when evidence is not enough]

Aortic stenosis is the most common valve disease and transcatheter aortic valve implantation (TAVI) is considered as an alternative to surgical valve replacement or to medical treatment in inoperable or high-risk patients. Although physicians have learned how to care for critically ill old patients and enable many to survive, major surgical procedures, operating on patients at very high risk, are often not suitable. Studies showed that selected cohorts of patients undergoing TAVI might have better outcomes in terms of survival and quality of life. However, mortality and safety data associated with the less invasive intervention do not always justify such new technologies for all patients with severe aortic stenosis, taking into account also the high cost associated. A systematic review of the available scientific literature has been performed. In this context, a DECIDE framework has been used providing a systematic and transparent approach for going from evidence to healthcare decisions. Before suggesting final recommendations, historical data of interventions done at regional level and regulatory decisions adopted in other countries following health technology assessment analysis, have been analyzed. All final recommendations based on this document have been discussed and reviewed with a working group done by the health operators directly involved in this technology within the regional health service context. Recommendations for the identification of patients suitable for TAVI are given together with a list of characteristics that should be required to all centers eligible for the performance of TAVI and with a procedure able to allow better quality assurance and prospective monitoring process of all new cases enrolled for such intervention. Impact of these recommendations will be measured using a regional registry collecting data on new patients undergoing TAVI.